Suction Mini-PCNL Versus Standard PCNL for the Management of 2-4cm Kidney Stones (NCT05088213) | Clinical Trial Compass
CompletedNot Applicable
Suction Mini-PCNL Versus Standard PCNL for the Management of 2-4cm Kidney Stones
China960 participantsStarted 2021-12-01
Plain-language summary
Percutaneous nephrolithotomy (PCNL) is recommended as the first-line treatment choice for kidney stones larger than 2cm in international guidelines . However, tract-related complications affecting renal parenchymal and blood vessels have always been a concern . The mini-PCNL technique which uses a smaller tract (≤18 Fr) has been introduced to decrease tract-related complications . Nevertheless, the smaller mini-PCNL tract necessitates fragmentationi of stones into smaller pieces before extraction, potentially prolonging the operative time. Additionally, higher pressure irrigation is often required to flush out fragments by vacuum cleaner effect. If the drainage of irrigation fluid is insufficient via a smaller tract, the intrarenal pressure (IRP) may build up, leading to pyelovenous backflow and infectious complications.
Suction application in mini-PCNL has the potential to enhance stone fragments removal efficiency, maintain low IRP, and decrease potential postoperative infection complications. In the pre-suction era, mini-PCNL achieved noninferior stone-free rates (SFR) and operative times compared to standard PCNL, along with benefits of reduced bleeding, less postoperative pain, and shorter hospital stay. However, high-level evidence regarding whether suction mini-PCNL can attain comparable outcomes to standard PCNL is still lacking.
Therefore, we have designed this multicenter, international, randomized controlled noninferiority trial comparing suction mini-PCNL with standard PCNL in the management of 2-4 cm kidney stones.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults aged 18-70 years.
. American Society of Anesthesiology (ASA) score of 1-2.
. Kidney stones measuring 2-4 cm in diameter on non-contrast computer tomography.
. Ability to provide written informed consent and adhere to trial requirements.
Exclusion criteria
. Anatomy abnormalities, such as urinary diversion, horseshoe kidney, transplanted kidney, or ureteropelvic junction obstruction.
. Untreated acute urinary tract infection (UTI).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stone free rate (SFR)
Timeframe: 72 hours after operation
2
Operation time
Timeframe: the time from percutaneous puncture to completion of double-J or nephrostomy tube placement
Trial details
NCT IDNCT05088213
SponsorThe First Affiliated Hospital of Guangzhou Medical University